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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030549
Receipt No. R000034868
Scientific Title Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery: a clinical result from a Japanese referral center
Date of disclosure of the study information 2017/12/29
Last modified on 2017/12/24

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Basic information
Public title Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery: a clinical result from a Japanese referral center
Acronym Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery
Scientific Title Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery: a clinical result from a Japanese referral center
Scientific Title:Acronym Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This retrospective study aimed to evaluate the short-term and long-term outcomes of self-expanding metal stents (SEMS) placement for malignant colorectal obstruction as a bridge in comparison with those of emergency surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes relapse-free survival
Key secondary outcomes primary anastomosis
stoma formation
laparoscopic surgery
lymph node dissection
complications
30-day mortality

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects were patients with acute malignant colorectal obstruction who were treated by either elective surgery after SEMS placement or emergency surgery between April 2001 and June 2016 at Showa University Northern Yokohama Hospital.
Key exclusion criteria Patients with decompression by nasal ileus tube or trans-anal tube as the first treatment, and a patient with signs of peritonitis by perforation were excluded from this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Yagawa
Organization Showa University Northern Yokohama Hospital
Division name digestive disease center
Zip code
Address Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken
TEL 045-949-7000
Email yagawayusuke@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Yagawa
Organization Showa University Northern Yokohama Hospital
Division name digestive disease center
Zip code
Address Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken
TEL 090-3089-5484
Homepage URL
Email yagawayusuke@yahoo.co.jp

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 24 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information This is a single institution retrospective study. Data regarding the treatment method, age, sex, location, pStage of tumor, treatment outcomes related to SEMS placement, treatment outcomes related to surgery, recurrence rate, and follow-up period were collected from the hospital records.

Management information
Registered date
2017 Year 12 Month 24 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034868

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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